Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitor in Patients With Chronic Myeloid Leukemia

NCT05259228 | Unknown

• 1 other identifier: 202008067RIND
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic myeloid leukemia (CML) consists of 3 clinical stages including chronic phase, accelerated phase and blast crisis. Patients may only survive for few more days to weeks once the disease progresses to blast crisis, even though they might have been stable for several years in the chronic phase. The standard treatment, continuous use of tyrosine kinase inhibitors (TKIs), improves long-term survival, and even may help patients achieve complete remission. Four TKIs are reimbursed by National Health Insurance in Taiwan. Among them, imatinib, nilotinib as well as dasatinib, and ponatinib are the first, second and third generations of TKIs, respectively. Many factors influence the disease control of CML, such as TKI type, genetic mutation and medication adherence. Only 69% of patients followed their physicians' recommendations in a local survey. The medication adherence of TKIs was compromised based on several clinical studies domestically and worldwide due to the slow progression in the chronic phase. Patients might hold or decrease the dose of TKIs on their own when they suffer side effects. Furthermore, the significant intra-subject variations of TKI plasma concentration and drug-drug and drug-food interactions which alter the metabolism of TKIs may lessen therapeutic effect and patient safety. Therefore, this study aims to develop and validate analytic methods of imatinib, dasatinib, nilotinib and ponatinib plasma concentrations. The investigators plan to build the pharmacokinetic models of these 4 TKIs and analyze the impacts of meals, adherence, hepatic enzyme inhibitors and inducers, antacids, proton pump inhibitors and H2 blockers, etc. Adverse drug reactions and treatment outcomes will be evaluated to determine the availability and feasibility of therapeutic drug monitoring of TKIs as part of routine service in pharmacist-led clinics.

Conditions

Tyrosine Kinase Inhibitor; Pharmacokinetics; Therapeutic Drug Monitoring

Keywords

tyrosine kinase inhibitor; pharmacokinetics; therapeutic drug monitoring

Outcome Measures

Primary Outcomes (5)

• Analytic methods of TKI plasma concentrations

  To develop and validate analytic methods of imatinib, dasatinib, nilotinib and ponatinib plasma concentrations.

  September, 2022 to December, 2025

• Minimum plasma concentration [Cmin] of TKI

  To measure the minimum plasma concentrations of imatinib, dasatinib, nilotinib and ponatinib.

  September, 2022 to December, 2025

• Patient adherence of TKI treatment

  To follow up and record the adherence of imatinib, dasatinib, nilotinib and ponatinib of each patient.

  September, 2022 to December, 2025

• Analysis of drug-drug interactions

  To analyze the impacts of hepatic enzyme (CYP) inhibitors and inducers, antacids, proton pump inhibitors and H2 blockers on the concentration of imatinib, dasatinib, nilotinib and ponatinib.

  September, 2022 to December, 2025

• Adverse drug reactions and treatment outcomes of TKI

  To evaluate the adverse drug reactions and treatment outcomes in order to determine the availability and feasibility of therapeutic drug monitoring of TKIs as part of routine service in pharmacist-led clinics.

  September, 2022 to December, 2025

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥ 20 year-old) who have already initiated or are going to receive imatinib, dasatinib, nilotinib, or ponatinib treatment at National Taiwan University Hospital/National Taiwan University Cancer Center from September 2022 to December 2025.

You may qualify if:

• Adult patients (≥ 20 year-old)
• Patients who meet the above criteria and have already initiated or are going to receive imatinib, dasatinib, nilotinib, or ponatinib treatment at National Taiwan University Hospital/National Taiwan University Cancer Center from September 2022 to December 2025

You may not qualify if:

• Patients who are unable to cooperate with blood drawing
• Patients who have not submit the informed consent

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Study Officials

• Shu-Wen Lin, PharmD, MS

  Graduate Institute of Clinical Pharmacy, National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Wen Lin, PharmD, MS

CONTACT

02 - 33668782; shuwenlin@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 28, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

TW (1)